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New cocktail shows promise against tough rectal tumors

NCT ID NCT06024356

Disease control Sponsor: Beijing Friendship Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study looked at whether adding an immune-boosting drug called thymalfasin to standard chemoradiotherapy and a PD-1 inhibitor could help shrink advanced rectal tumors before surgery. Researchers studied 47 patients with stage II/III mid-low rectal cancer. The main goals were to see how many patients had no cancer left in the surgical specimen and how long they lived without the cancer coming back.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
thymalfasin (thymosin-alpha 1) combined with chemoradiotherapy and a PD-1 inhibitor
What this could lead to
If this combination works better than standard treatment, it could point toward a more effective way to shrink rectal tumors before surgery and improve long-term survival.
What could go wrong
This is a small, single-center, retrospective study, not a large randomized trial. The results may not apply to all patients, and adding more drugs can increase side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

47 people

The number who actually took part.

Started

Sep 2023

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

locally advanced mid-low rectal cancer

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with rectal adenocarcinoma must satisfied all the following conditions: 1. Stage II/III LARC (cT1-4aN0-2M0); 2. Tumor distal location≤10 cm from anal verge (MRI diagnosed); * Patients regardless of gender with aged≥18 years * ECOG score of 0 or 1 * Physical and viscera function of patients can withstand major abdominal surgery Exclusion Criteria: * Current or previous active malignancy other than rectal cancer； * Patients underwent major surgery within 4 weeks prior to neoadjuvant therapy； * Patients have any condition affects the absorption of capecitabine through gastrointestinal tract； * Patients have severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases; * Patients with severe concomitant diseases with estimated survival≤5 years； * Patients with present or previous moderate or severe liver and kidney damage； * Patients preparing for or previously received organ or bone marrow transplant； * Patients who have received immunosuppressive or systemic hormone therapy within 1 month prior to the start of neoadjuvant therapy； * Patients with congenital or acquired immune deficiency (such as HIV infection)； * Pregnant or lactating women.

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Conditions

The condition(s) this trial relates to.

colorectal neoplasm rectal cancer rectal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal neoplasms

Contacts and locations

Locations

  • Beijing Friendship Hospital, Capital medical University

    Beijing, Xicheng Dis, 100050, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.